Collapsible tube for hemostasis

ABSTRACT

Collapsible tube embodiments may be used to promote hemostasis at surgical sites or any other suitable location. In some cases, vascular closure device embodiments may include collapsible tube embodiments in order to promote hemostasis at a surgical site during a vascular closure procedure.

RELATED APPLICATIONS

This application claims priority from U.S. Provisional PatentApplication Ser. No. 62/587,341, filed on Nov. 16, 2017, by ThomasLarzon et al. titled “Suture Tube”, which is incorporated by referenceherein in its entirety.

BACKGROUND

In many percutaneous cardiovascular procedures, a catheter is insertedinto an artery, such as the femoral artery, through a percutaneousvascular access. The catheter may be inserted, typically over aguidewire, directly into an artery (a “bareback” procedure), or thecatheter may be inserted through a vascular introducer. When theprocedure is complete, the physician removes the catheter and thenremoves the introducer from the vessel (if one was used). The physicianthen must prevent or limit the amount of blood that leaks through thevascular access. Physicians currently use a number of methods to closethe vascular access, such as localized external compression,suture-mediated closure devices, plugs, gels, foams and similarmaterials.

However, such closure procedures may be time consuming, and may consumea significant portion of the time of the procedure. In addition,existing methods are associated with complications such as hematoma orthromboses. Still further, some of such procedures, particularlysuture-mediated closure devices, are known to have high failure rates inthe presence of common vascular disease such as atherosclerosis andcalcification.

SUMMARY

Some embodiments of a vascular closure device may include a housingincluding an elongate configuration with an axial length greater than atransverse dimension thereof, a proximal end, a distal end and a distalsection. The vascular closure device may further include a plurality ofanchor deployers configured to extend from the distal section of thehousing. Each of the anchor deployers may include a deployment rod whichis slidably disposed relative to the housing and which includes anelongate resilient configuration and a distal end that extends distallyand radially outward from the distal section of the housing. Each anchordeployer may also include an anchor which is removably secured to thedistal end of the deployment rod and which is configured to penetratetissue in a distal direction and optionally prevent tissue penetrationin a proximal direction. Each of the anchor deployers may also include afilament that may be slidably disposed within the housing and have adistal end which is secured to the anchor. A collapsible tube may bedisposed over and optionally secured to a distal section of the filamentproximal of and adjacent to the anchor. In some cases, the collapsibletube may include an elongate configuration having an axial lengthgreater than a transverse dimension thereof and a wall structure that isconfigured to shorten in an axial length and radially expand upon axialcompression. In some instances, the respective filaments of theplurality of anchor deployers may be slidably disposed within thehousing adjacent each other at the distal section of the housing.

Some embodiments of a method of preventing blood leakage from a closuresite of a passage in a tissue layer may include disposing a distal endof a housing of a vascular closure device to a position adjacent thepassage in the tissue layer. A plurality of anchor deployers may bedeployed from a distal section of the housing in a distal and radiallyoutward direction from the housing into the tissue layer in positionsdisposed about the passage in the tissue layer. The method may alsoinclude penetrating the tissue layer with the plurality of anchordeployers of the vascular closure device and extending each of theplurality of anchor deployers distally through the tissue layer until aproximal end of a collapsible tube of each of the plurality of anchordeployers extends distally beyond a lower surface of the tissue layer.Once so deployed, an anchor of each of the anchor deployers may beproximally retracted by proximally retracting a filament which issecured thereto. The method may also include axially compressing thecollapsible tube of each of the plurality of anchor deployers betweenthe respective anchor and lower surface of the tissue layer by applyingtension to the filament which is secured to the anchor and which isdisposed within an inner lumen of the collapsible tube. The collapsibletube may be axially compressed until the collapsible tube shortens inaxial length and expands in an outward radial direction adjacent thepassage. Tension may also be applied to the filaments from the distalsection of the housing to reduce a distance between the anchors drawingthe anchors and adjacent tissue of the tissue layer radially inward soas to reduce the size of the passage in the tissue layer.

Some embodiments of a hemostasis device may include a housing having anelongate configuration with an axial length greater than a transversedimension thereof, a proximal end, a distal end and a distal section.The hemostasis device may also include an anchor deployer having adeployment rod which is slidably disposed relative to the housing andwhich includes an elongate resilient configuration and a distal end thatextends distally and radially outward from the distal section of thehousing. An anchor may be removably secured to the distal end of thedeployment rod and may be configured to penetrate tissue in a distaldirection and optionally prevent tissue penetration in a proximaldirection. A filament may be slidably disposed within the housing andmay include a distal end which is secured to the anchor. A collapsibletube may be disposed over a distal section of the filament proximal ofthe anchor. The collapsible tube may include an elongate configurationhaving an axial length greater than a transverse dimension thereof and awall structure that is configured to shorten in an axial orientation andexpand radially outward upon axial compression.

Some embodiments of a method of preventing blood leakage from a tissuelayer may include disposing a distal end of a housing of a hemostasisdevice at a position adjacent the tissue layer and deploying an anchordeployer from a distal section of the housing in a distal direction fromthe housing into the tissue layer. The method may also includepenetrating the tissue layer with the anchor deployer and extending theanchor deployer distally through the tissue layer until a proximal endof a collapsible tube of the anchor deployer extends distally beyond alower surface of the tissue layer. Once so deployed, an anchor of theanchor deployer may be proximally retracted by proximally retracting afilament which is secured thereto thus axially compressing thecollapsible tube between the anchor and lower surface of the tissuelayer by applying tension to the filament which is secured to the anchorand which is disposed within an inner lumen of the collapsible tube. Thecollapsible tube may be axially compressed until the collapsible tubeshortens in axial length and expands in an outward radial direction.

Certain embodiments are described further in the following description,examples, claims and drawings. These features of embodiments will becomemore apparent from the following detailed description when taken inconjunction with the accompanying exemplary drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 schematically exemplifies a first embodiment of a vascularclosure device.

FIGS. 2A and 2B show the creation of a tissue lock using the vascularclosure device.

FIGS. 2C and 2D illustrate a closure sequence for treatment of anunwanted passage through a wall of a blood vessel.

FIGS. 3A and 3B illustrate an engagement member, exemplified as ananchor element.

FIGS. 4A and 4B illustrate the operation of an anvil member thatfunctions as a deployable positioning feature.

FIG. 5 is an elevation view of a vascular closure device embodiment.

FIG. 6 is a front view of the vascular closure device of FIG. 5.

FIG. 6A is a section view of a distal portion of the housing of thevascular closure device of FIG. 6.

FIG. 7 shows an embodiment of an anchor deployer of the vascular closuredevice of FIG. 1.

FIG. 7A is a transverse cross section view of the anchor deployer ofFIG. 7 taken along lines 7A-7A of FIG. 7.

FIG. 8 shows an embodiment of an anchor deployer of the vascular closuredevice of FIG. 1.

FIG. 9A is a section view of a proximal section of an anchor deployerembodiment.

FIG. 9AA is a transverse cross section of the proximal section of theanchor deployer embodiment of FIG. 9A taken along lines 9AA-9AA of FIG.9A.

FIG. 9B is a section view of a proximal section of an anchor deployerembodiment.

FIG. 9C is a section view of a proximal section of an anchor deployerembodiment.

FIG. 10 is an elevation view in section of a distal section of a housingof the vascular closure device of FIG. 1 disposed adjacent an accesspassage in a fascia tissue layer with anchor deployers being deployed inthe fascia tissue layer.

FIG. 11 shows deployment rods of the anchor deployers of the vascularclosure device being proximally withdrawn back into the housing of thevascular closure device.

FIG. 12 shows the anchors, associated filaments and collapsible tubes ofthe vascular closure device disposed below the fascia tissue layer priorto tensioning of the filaments and compression of the collapsible tubes.

FIG. 13 illustrates tensioning of the filaments of the vascular closuredevice.

FIG. 14 shows the filaments of the vascular closure device in atensioned state with the collapsible tubes in a compressed and radiallyexpanded state prior to deployment of a lock ring over the filaments.

FIG. 15 shows the filaments of the vascular closure device in atensioned state with the collapsible tubes in an axially compressed andradially expanded state after deployment of the lock ring and formationof thrombus between the compressed collapsible tubes.

FIG. 16 illustrates an embodiment of a hemostasis device.

FIG. 17 is an enlarged view in partial section of a distal section of ahousing of the hemostasis device embodiment of FIG. 16.

FIG. 18 shows an anchor deployer embodiment of the hemostasis deviceembodiment of FIG. 17 disposed through a fascia tissue layer.

FIG. 19 shows the hemostasis device of FIG. 18 with a deployment rodthereof being proximally retracted.

FIG. 20 shows proximal tension being applied to a filament of thehemostasis device embodiment of FIG. 19.

FIG. 21 shows a collapsible tube of the hemostasis device embodiment ofFIG. 20 in an axially collapsed and radially expanded deployed state.

The drawings are intended to illustrate certain exemplary embodimentsand are not limiting. For clarity and ease of illustration, the drawingsmay not be made to scale, and in some instances, various aspects may beshown exaggerated or enlarged to facilitate an understanding ofparticular embodiments.

DETAILED DESCRIPTION

After a minimally invasive vascular procedure, a hole in the form of anaccess passage or the like may be left in a major vessel or othersurgical target of interest at an access site that may need to beclosed. Methods for percutaneous closure of such a hole may includeremote suturing of the vessel, plugging the hole, and remote suturing ofthe fascia adjacent to the vessel. Certain device and method embodimentsdiscussed herein are directed to mechanical closure of an access passagein the fascia tissue layer adjacent to an access hole in a vessel suchas an artery or vein of a patient while minimizing blood leakage fromthe closure site. Certain device and method embodiments discussed hereinmay also be directed to mechanical closure of an access passage in thefascia tissue layer adjacent any other bodily structure that may requirehemostasis including an abdominal cavity of a patient. Such device andmethod embodiments may be appropriate for any surgical procedure inwhich access is required via dissection of a fascia layer or any othertissue layer adjacent a surgical site of interest within the patient'sbody. Some of these embodiments may also be applicable to direct closureof an arterial wall in some instances. Some vascular closure device andmethod embodiments discussed herein may provide a robust and easy-to-usedevice for closing a vascular access hole after a minimally invasiveprocedure. In some cases, vascular closure device embodiments discussedherein may be useful for closing large vascular access holes. Inaddition, certain vascular closure device and method embodiments arediscussed in U.S. patent application Ser. No. 15/277,542, filed Sep. 27,2016, by Thomas Larzon, et al., entitled VASCULAR CLOSURE DEVICE, whichis incorporated by reference in its entirety.

The following discussion of the device and method embodiments of FIGS.1-4B is directed generally to closure of a vascular access passage aswell as axial positioning of certain portions of vascular closure deviceembodiments during such a closure procedure. Such axial positioningdevices and methods may be applied to and used with any appropriatevascular closure device or method of embodiment discussed herein.Turning now to the drawings, and to FIG. 1 in particular, an embodimentof a vascular closure device 10 is introduced percutaneously over aguide wire 8 into a blood vessel/artery 5, through the skin 1 and thefascia lata 2 of a patient. An optional anvil member 9 may be arrangedinside the blood vessel 5 to create a reference point along an axialorientation to the engagement members 11 and/or for controlling bleedingfrom an inner lumen of the artery 5. The engagement members 11 may thenbe placed and released through the vascular closure device 10 and mayattach to fascia tissue 3 proximate to the blood vessel 5 and mayinvolve the fascia membrane 3 (fascia iliacus), but, in some instances,not a wall 22 of the blood vessel 5. The engagement members 11 may forexample be pushed out of the vascular closure device 10 and into thefascia membrane 3 using deployment members provided as pusher rods 12arranged in independent lumens provided with the vascular closure device10, for example through a pusher assembly in a common lumen thatsimultaneously deploys all engagement members 11, through aspring-loaded mechanism or the like. For some embodiments, theengagement members 11 may be connected with a single filament such as asuture or a plurality of filaments or sutures 13. In FIG. 1 there isfurther shown a femoral vein 4, a femoral nerve 6 andadjacent/interstitial tissues 7.

With further reference to FIGS. 2A and 2B, the suture 13 may for examplebe routed through each of the engagement members 11 in sequence. Inparticular, one suture 13 may be looped through each of the engagementmembers 11 in sequence, or a separate suture 13 may be attached to eachengagement member 11. The tissue, e.g. fascia membrane 3, may thenpulled together in a radially inward direction towards an access passagein the fascia layer 3 with the suture 13 connected to the engagementmembers 11. When pulled together, the tissue/fascia membrane 3 istightened towards the center and the access passage therethrough and maythen create a tissue lock, thereby indirectly sealing the access hole inthe artery 5. That is, a distance between the initial position of theengagement members 11 and a distance between the engagement members oncethe engagement members 11 have been moved radially inward towards eachother is thereby reduced. When tightening the fascia membrane 3 theanvil member 9 may be removed from the artery 5.

Referring to FIGS. 2C and 2D, an embodiment of a vascular closuresequence is shown whereby a passage through a wall 22 of the vessel 5such as the blood vessel shown is treated such that leakage of bloodfrom the interior volume of the blood vessel (not shown) is slowed orstopped to a clinically acceptable degree. As seen in FIG. 2C, a passagein the wall of the blood vessel, specifically, the femoral artery 5, isdisposed in general alignment with a passage through the fascia tissuelayer 3 disposed proximate to an outer surface of the femoral artery 5.For this particular exemplary embodiment, the tissue layer disposedoutside of and proximate to the outer surface of the femoral artery 5 isthe fascia iliacus 3. For purposes of this general discussion, thephrase “in general alignment” as applied to the respective passages maymean at least that an appropriately sized elongate device such as acatheter or sheath may pass through both passages without significantrelative lateral displacement between the tissue 3 and artery 5.

In addition, in some cases, the tissue layer 3 may be disposedsufficiently proximate the outside surface of the blood vessel 5 suchthat gathering and approximation of the fascia tissue 3 which isdisposed about the passage through the tissue 3 so as to close thepassage through the tissue/fascia membrane 3 and form a tissue lock issufficient to tighten and displace the closed gathered tissue/fasciamembrane 3 against the outer surface of the artery 5 which is adjacentthe passage through the artery 5 as shown in FIG. 2D.

When the gathered tissue 3 has been displaced and deflected so as to bedisposed against the passage of the artery 5 and wall of the artery 5disposed about the passage in the artery 5, this mechanicalapproximation will typically be sufficient in order to achieve aclinically sufficient slowing or stoppage of blood leakage from thepassage in the artery 5 in order to permit closure of an access sitethrough the patient's skin 1 adjacent the passages. In some instances,an inner surface of the tissue layer 3 disposed proximate to the outersurface of the blood vessel 5 may be separated from the outer surface ofthe blood vessel in the region of the respective passages therethroughby a distance of up to about 10 mm, more specifically, up to about 5 mm.

With further reference to FIGS. 3A and 3B, there is conceptuallyillustrated an engagement member, exemplified as an anchor element 15.In FIG. 3A, the anchor element 15 is shown as initially deployed, sothat it slides easily in the direction away from a deployment point.Note that the deployment point may optionally be deflected toward thetissue/fascia membrane 3 to promote engagement. FIG. 3B shows the anchorelement 15 after motion has been reversed toward the deployment point,and the anchor element 15 has embedded into the tissue/fascia membrane3. That is, a tip 17 of the anchors element 15 is in one embodimenthook-shaped, so that it easily slides outward without engaging thetissue/fascia membrane 3. However, once the anchor element 15 isretracted, at least the tip 17 of the anchor element 15 is adapted tomechanically engage with the tissue/fascia membrane 3.

FIGS. 4A and 4B conceptually illustrate the operation of an anvil memberexemplified as a deployable positioning feature 20. In FIG. 4A,deployable positioning feature 20 may be inserted through the wall 22and into the interior volume of the blood vessel, such as the femoralartery 5. The deployable positioning feature 20 may be structuredsimilar to an umbrella (using a mesh material), where the deployablepositioning feature 20 in a radially collapsed form may be inserted intothe artery 5. Once within the artery 5, with further reference to FIG.4B, the deployable positioning feature 20 may be “unfolded” and radiallyexpanded from the collapsed form such that a total surface areaproximate to the longitudinal axis of the deployable positioning feature20 is increased and thus may be retracted towards the interior wall ofthe artery 5. Accordingly, a reference point may be thereby establishedfor further operation of the vascular closure device 10.

Some vascular closure device embodiments 24, as exemplified by theembodiments of FIGS. 5-15 which are discussed herein, may include aplurality of collapsible tubes 26 which may be utilized tohemostatically close, and prevent additional bleeding from, a vascularaccess site and target vessel 5 after a percutaneous cardiovascularprocedure or the like has been performed. The vascular closure device 24and method embodiments may include a plurality of anchor deployers 28each of which may include a filament 30 which is secured to an anchor32, a deployment rod 34, and a collapsible tube 26 which is disposedover and optionally secured to a distal end of the filament 30. Uponplacement of a distal section of a housing 36 of the vascular closuredevice 24 near the vascular access site and deployment of the pluralityof anchor deployers 28 into tissue 3, the anchors 32, filaments 30, andcollapsible tubes 26 of the anchor deployers 28 may be manipulated suchthat fascia tissue layer 3 surrounding the access passage 38 (see FIG.10) at the vascular access site and the collapsible tubes 26 providehemostatic closure of the access passage 38 and access hole 44 in thetarget artery 5 of the vascular access site. Such devices and proceduresmay also be applicable for use in the treatment of access passagesdisposed in any other suitable structures beneath a fascia layer 3 (orany other suitable tissue layer) including veins, such as the femoralvein 4, abdominal cavities, and the like. Some such vascular closuredevice embodiments may include about 2 anchor deployers 28 to about 8anchor deployers 28, more specifically, about 3 anchor deployers 28 toabout 5 anchor deployers 28.

The vascular closure device 24 may be placed within a vascular accesspassage 38 created during the percutaneous cardiovascular procedure inorder to access a target vessel 5. The anchor deployers 28 may then beextended distally and radially outward via the deployment rods 34 fromthe vascular closure device 24 and though tissue, such as a fasciatissue layer 3, that is adjacent to both the vascular access channel 38and the target vessel 5. The deployment rods 34 may then be proximallyretracted into the housing 36 of the vascular closure device 24, and thefilaments 30 may be proximally tensioned. In some instances, proximaltensioning of the filaments 30 may result in a reorientation of eachrespective anchor 32 secured thereto. The reorientation of each of theplurality of respective anchors 32 may then result in mechanical captureof adjacent tissue 3 by each anchor 32 upon tensioning of the filaments30. In some cases, after tensioning, a proximal portion of each filament30 may be slidably disposed within a filament grip such as the lock ring40 disposed on a distal end 42 of the housing 36 of the vascular closuredevice 24. Once deployed from the distal end 42 of the housing 36, thelock ring 40 may act to secure the filaments 30 relative to each otherand relative to the fascia tissue layer 3 after tensioning resulting incompression of tissue between each filament 30 and each of therespective anchors 32. Thus tensioning of the filaments 30 may result incompression of the tissue 3 surrounding the access passage 38 in thefascia tissue layer 3 and an adjacent the access hole 44 in the targetvessel 5, with the compressed fascia tissue layer forming a tissue lockin the form of a hemostatic seal around the access passage 38 and theaccess hole 44 in the artery 5.

As the filaments 30 are proximally retracted a proximal portion 46 ofeach collapsible tube 26 disposed thereon may be mechanically capturedand stopped by surrounding tissue 3, while the distal end 48 of eachcollapsible tube 26 remains secured to the distal end 48 of the filament30. Thus, during retraction of the filaments 30, a compressive axialload may be applied to each collapsible tube 26 by the respectivefilaments 30 disposed therein, resulting in buckling of each collapsibletube 26 about the respective filament 30. The buckling of eachcollapsible tube 26 may result in a reduction in the axial length of thecollapsible tube 26 and outward radial expansion of the diameter of thecollapsible tube 26. Depending on the configuration of collapsible tubeembodiments 26, axial buckling of the collapsible tubes 26 may occur ina random fashion or may be predetermined to occur in a regularsinusoidal fashion, such as in an accordion fashion, by preconditioningthe collapsible tubes 26 with wrinkles, stiffening rings, uneven wallthicknesses, and/or any other suitable geometric feature such asperiodic variation in radius along an axial length of the collapsibletubes 26.

Further, the collapsible tubes 26 may be constrained by the respectivefilaments 30 and lock ring 40 such that upon final tensioning of thefilaments 30 the axially compressed collapsible tubes 26 surround thevascular access channel 38 and hole 44 in the target vessel 5 maythereby provide additional hemostasis to the closed access passage 38.Thus upon deployment the collapsible tubes 26 may reduce bleedingthrough puncture holes 50 created by the insertion of the anchordeployers 28, from the access passage hole 44 in the target vessel 5,and around the access passage 38 in the fascia tissue layer 3 or thelike by mechanically blocking the flow of blood around the filaments 30,by promoting the clotting of blood about the vascular access site, or bysome combination of these two mechanisms. In some instances, the radialexpansion of the proximal portions 46 of the collapsible tubes 26 duringtensioning of the filaments 30, as well as the axial collapse and radialexpansion of the collapsible tubes 26 in general, may also allow thecollapsible tubes 26 to serve as anchors that resist proximaldisplacement through the puncture holes 50 during tensioning. As such,vascular closure device embodiments 24 are envisioned that may functionas discussed above without the use of anchors 32 that are configured toresist proximal displacement through punch holes 50 upon tensioning ofthe filaments 30.

For some embodiments, the collapsible tubes 26 may be fabricated from athrombogenic material which actively promotes hemostasis such ascollagen or any other suitable biologic or synthetic thrombogenicmaterial. In some cases the collapsible tubes 26 may be fabricated fromhydrophilic materials (such as a hydrogels and the like) which mayexpand upon interaction with fluids which are present within the tissueadjacent the collapsible tubes 26. Such expansion of collapsible tubeembodiments 26 may provide additional thrombogenicity to the vascularaccess site and puncture holes 50. Thus the collapsible tubes 26 mayachieve a hemostatic effect via a mechanical tampon or tamponade effectachieved by the buckling of the collapsible tubes 26 or by thebiological\absorbent properties of the material(s) of the collapsibletubes 26 as shown in FIG. 15. Further collapsible tube embodiments 26may be configured to easily slip over a respective filament 30, and maybe configured with a relatively small outer transverse dimension suchthat the collapsible tube 26 does not interfere with or adversely affectthe performance of the filament 30 during such a vascular closureprocedure embodiment.

Referring to FIG. 5, the vascular closure device embodiment 24 includesa plurality of anchor deployers 28 and respective collapsible tubes 26,filaments 30 disposed therein and anchors 32. The vascular closuredevice 24 may include the housing 36 having an elongate configurationthat is to say that an axial length of the housing 36 may be greaterthan a transverse dimension of the housing 36. The housing 36 may alsoinclude a proximal end 52, a distal end 42, and a distal section 54. Theplurality of anchor deployers 28 may be suitably disposed within aninterior volume of the housing 36 as shown in FIG. 6A. Each anchordeployer 28 may be configured to extend from the distal section 54 ofthe housing 36 and into target tissue during a vascular closureprocedure. Each anchor deployer 28 may include the deployment rod 34,the anchor 32, the filament 30, and the collapsible tube 26 that may bedisposed over the filament 30. Each deployment rod 34 may have anelongate resilient configuration, and may be slidably disposed relativeto the housing 36 such that a distal end 56 of the deployment rod 34 mayextend distally and radially outward from the distal section 54 of thehousing 36 upon deployment of the respective anchor deployer 28.

Each anchor 32 of an anchor deployer 28 may be removably secured to thedistal end 56 of the deployment rod 34 such that after penetration ofthe tissue layer 3 in a distal direction, the anchors 32 may slide offthe distal end of the deployment rod 34 when the deployment rod 34 isproximally retracted. Each anchor 32 may be configured to penetratetissue 3 in a distal direction and optionally prevent tissue penetrationin a proximal direction. This configuration of the anchors 32 may beused to facilitate the deployment of the anchor deployers 28 distallyinto the target tissue 3 while allowing for the mechanical capture ofthe respective anchors 32 by surrounding tissue 3 and the associatedcollapsible tube 26 after retraction of the deployment rods 34 andproximal tensioning of the filaments 30.

Each anchor deployer 28 of the vascular closure device 24 may alsoinclude the filament 30 that may be slidably disposed within an innerlumen of the housing 36. The distal end 58 of the filament 30 may besecured to the anchor 30. In some instances, each filament 30 of theplurality of anchor deployers 28 may be slidably disposed within thehousing 36 such that each filament 30 is disposed adjacent to anotherfilament 30 at the distal section 54 of the housing 36 (see FIG. 6) andmay optionally pass through a common lumen of the housing 36. Eachanchor deployer 28 may also include a collapsible tube 26 that may bedisposed over and secured to a distal section 60 of the respectivefilament 30, the distal section 60 of the filament 30 being disposedsuch that it is proximal of and adjacent to the anchor 30. In somecases, each collapsible tube 26 may have an elongate configuration suchthat an axial length of the collapsible tube 26 may be greater than atransverse dimension of the collapsible tube 26. Additionally, eachcollapsible tube 26 may have a wall structure that may be configured toshorten in axial length and radially expand upon axial compression. Insome cases, the collapsible tubes 26 may be configured to buckle in anaxial orientation upon axial compression of the collapsible tube 26.

In some instances, the housing 36 may include a guidewire lumen 62 whichmay extend the axial length of the housing 36 from the proximal end 52to the distal end 42 and which may include an eccentric lumen in somecases disposed towards an outside portion of the housing 36. The guidewire lumen 62 may be configured to allow for the passage of theguidewire 8 through the housing. In some cases, the guidewire 8 mayremain within the target vessel 5 and within a vascular access channel38 created during the percutaneous cardiovascular procedure. Theguidewire lumen 62 disposed within the housing 36 of the vascularclosure device 24 allows for the vascular closure device 24 to becoupled to the guidewire 62, thereby allowing for the tracking of thevascular closure device 24 along the guidewire 8 within the vascularaccess channel 38 as shown in FIGS. 10-12.

The vascular closure device 24 may also include a handle 64 that may besecured to the proximal end 52 of the housing 36. The handle 64 may beutilized in order to grasp and manipulate the vascular closure device 24during a vascular closure procedure, and may include features whichcontrol the insertion of the anchor deployers 28 (via distal extensionof the deployment rods 34), proximal retraction of the deployment rods34, proximal tensioning of the filaments 30, and in some casesdeployment of the lock ring 40 The handle 64 may include a Luer lockfitting 66 which is in fluid communication with the guidewire lumen 62and which allows for access through the handle 64 to the guidewire lumen62 which may be disposed within the housing 36.

The handle 64 may also include a rod pusher 68 that may be operativelycoupled to each deployment rod 34. In some cases the rod pusher 68 maybe operatively coupled to a proximal end of each deployment rod 34. Therod pusher 68 may be configured such that it can slide within the handle64 both distally and proximally, thereby allowing for the rod pusher 68to be utilized in order to distally extend or proximally retract eachdeployment rod 34 during a vascular closure procedure. The handle 64 mayalso include a filament tensioner 70 which may be operatively coupled toeach filament 30 such that tension applied to the filament tensioner 70in a proximal direction applies a corresponding proximal tension to thefilaments 30. The filament tensioner 70 may be may be configured suchthat it can slide proximally within the handle 64, thereby allowing forthe filament tensioner 70 to be utilized in order to proximally tensionthe filaments 30.

Upon deployment the collapsible tube embodiments 26 which are discussedherein may be utilized in order to reduce the chance of bleeding throughpuncture holes 50 created by the insertion of the anchor deployers 28,from the hole 44 in the target vessel 5, and the access passage 38around the vascular access site by mechanically blocking the flow ofblood around the filaments 30, by promoting the clotting of blood aboutthe vascular access site, or by some combination of these twomechanisms. As such the collapsible tube embodiments 26 may beconfigured in order to facilitate buckling upon axial compression of thecollapsible tube 26. In some cases, such axial buckling may lead to ashortening of the axial length of the collapsible tube embodiments 26and an expansion outward in a radial direction of the collapsible tube26 to create a larger transverse profile of the collapsible tube 26.Further, in some cases the collapsible tubes 26 may be fabricated from amaterial which may be thrombogenic such that the collapsible tubes 26induce clotting, or from a material which absorbs fluids and expands inorder to increase the volume of the collapsible tube 26 upon deployment.

Embodiments of collapsible tubes 26 are shown in FIGS. 7, 7A, 8, 9A, 9B,and 9C. Each collapsible tube embodiment 26 may have an elongatedconfiguration wherein the axial length of the collapsible tube 26 may begreater than the transverse dimension of the axial tube. Eachcollapsible tube embodiment 26 which is discussed herein may optionallyhave an axial length of about 3 mm to about 15 mm, and an outertransverse dimension of about 0.5 mm to about 2 mm. In some instances,the collapsible tube embodiments 26 may be configured for ease ofinsertion during anchor deployer actuation, ease of collapsible tubewall structure bucking during tensioning of the filaments, mechanicalstoppage against the fascia tissue layer 3 against which the collapsibletubes 26 are compressed during filament tensioning or any combination ofthese configurations.

FIG. 7 depicts a collapsible tube embodiment 26 having a distal section72 which tapers distally to a reduced outer transverse dimension. Thepurpose of the distal section 72 which tapers is to facilitate theinsertion of the collapsible tube 26 through a puncture hole 50 duringdistal deployment of the respective anchor deployer 28. In some cases, adistal end 48 of the collapsible tube 26 may be secured to the filament30 in a position which is proximal of and adjacent to the anchor 32. Insome cases, the collapsible tube 26 may be secured to the filament 30with an adhesive 74 which may be disposed between an inner surface ofthe distal section 72 of the collapsible tube 26 and an outer surface ofthe filament 30 as shown in FIG. 7A. The adhesive 74 may be any suitableadhesive such as cyanoacrylate, UV-cured adhesive, or the like. In somecases, the collapsible tube 26 may be welded or fused to the filament 30wherein material contained within the distal section 60 of the filament30 may be thermally fused to material contained within the distalsection 72 of the collapsible tube 26 such that the distal section 72 ofthe collapsible tube 26 is adjacent to the anchor 32 after the fusionprocess. In some instances, in order for the collapsible tubeembodiments 26 to axially compress and radially expand properly whensubject to axial compression, it may be desirable for the collapsibletubes 26 to be bonded or otherwise secured to the filament 30 only atthe distal end of the filament 30 with the remainder of the collapsibletube 26 having an inner lumen sized to allow an inner surface of theinner lumen of the collapsible tube 26 to slide freely in an axialdirection over an outer surface of the filament 30. For someembodiments, an axial length of the bond section between the filament 30and the distal end of the collapsible tube 26 may be up to about 10percent of an overall axial length of the collapsible tube 26. For someembodiments, the distal end 48 of the collapsible tube 26 may be secureddirectly to the anchor 32 as shown in FIG. 8. The distal end 48 of thecollapsible tube 26 may be secured directly to the anchor 32 by theadhesive 74 such as cyanoacrylate, UV-cured adhesive, thermal bonding,welding, mechanical crimping or the like.

In some cases, the wall structure 76 of the collapsible tubes 26 may bemodified in order to facilitate buckling of the collapsible tubes 26upon proximal tensioning of the filaments. The collapsible tubeembodiments 26 which are depicted in FIGS. 7 and 8 each incorporate atleast one longitudinal slit 78 in a middle section 80 of the wallstructure 76 of each collapsible tube 26. Each collapsible tubeembodiment 26 which is discussed herein may include a plurality oflongitudinal slits 78 within the wall 76 of the middle section 80, insome instances the longitudinal slits 78 may extend entirely through thewall 76 from an outside surface to an inside surface of the wall 76. Insome other instances the longitudinal slits 78 may extend only partiallythrough the wall 76 of the collapsible tube 26. For some embodimentsdiscussed herein, each collapsible tube 26 may have from about 1 toabout 5 longitudinal slits disposed within the wall structure 76thereof. Additionally, an axial length of each longitudinal slit 78 maybe from about 25 percent to about 75 percent of an axial length of therespective collapsible tube 26. As discussed above, such structures maybe useful for effecting axial buckling of the collapsible tubes 26 in apredetermined regular sinusoidal fashion, such as in an accordionfashion.

As has been discussed above, materials that may be used for someembodiments of the collapsible tubes 26 may have thrombogenic orhydrophilic properties in order to reduce bleeding from the accesspassage 38 or through the puncture holes 50 created during thedeployment of the anchor deployers 28. Some materials that may be usedfor the collapsible tube embodiments 26 that are discussed herein may beselected from the group consisting of polyurethane, polyethyleneterephthalate (PET), polyetherether keytone PEEK,polytetrafluoroethylene (PTFE), acrylic, silicone, polypropylene, andpolyester or the like. Some materials that may be used for thecollapsible tube embodiments 26 that are discussed herein may includethrombogenic materials may include collagen, fibrin, fibrinogen,gelatin, polylactic acid (PLA), polyglycolic acid (PGA), alginate andfibronectin or the like. Some materials that may be used for thecollapsible tube embodiments 26 that are discussed herein may includehydrogel materials which absorb fluids from surrounding tissue andexpand. Hydrogel collapsible tube materials may include fibrin,collagen, gelatin, hyaluronic acid, alginate, agarose, poly(ethyleneglycol), poly(acrylic acid), poly(vinyl alcohol), polypeptides, andpoly(vinyl pyrrolidone). Further some materials that may be used for thecollapsible tube embodiments 26 that are discussed herein may includebiodegradable or bio-absorbable materials, such as poly(lactic acid),which may be absorbed by the surrounding tissue over time.

In some instances, during proximal tensioning of the filaments 30 andaxial compression of the collapsible tubes 26, it may be advantageousfor a proximal section 46 of each collapsible tube 26 to be mechanicallystopped in a proximal direction by surrounding tissue of a bottomsurface of the fascia tissue layer 3 such that the collapsible tube 26is not retracted proximally through the puncture hole 50 created duringthe deployment of the respective anchor deployer 28. FIGS. 9A, 9B, and9C show collapsible tube embodiments 26 having proximal sections 46which are configured to expand and be mechanically stopped in a proximaldirection by a bottom surface of the fascia tissue layer 3 or any othersurrounding tissue during proximal tensioning of the filaments 30.

In some instances, the proximal section 46 of a collapsible tubeembodiment 26 may have at least one proximal slit 82 through the wall 76of the collapsible tube 26, the proximal slit 82 extending distally fromthe proximal end 84 of the collapsible tube 26 as shown in FIGS. 9A and9AA. In some cases, the proximal section 46 of the collapsible tube 26may have about 1 to about 5 slits, and an axial length of each proximalslit 82 may be from about 1 mm to about 4 mm. During proximal tensioningof the filaments 30, the proximal slits 82 may allow for outward radialexpansion of the proximal section 46 against the bottom surface of thefascia tissue layer 3 or any other adjacent tissue, with the resultbeing the proximal section 46 being mechanically stopped in a proximalaxial direction by the bottom surface of the fascia tissue layer 3during tensioning of the filaments 30 and the proximal section 46 isprevented from being pulled through the puncture holes 50 back throughthe fascia tissue layer.

FIG. 9B depicts the proximal section 46 of a collapsible tube embodiment26 wherein a wall thickness of the wall structure 76 of the collapsibletube 26 tapers to a reduced wall thickness from a position which isdistal of the proximal end 84 of the collapsible tube 26 to a positionat the proximal end 84 of the collapsible tube 26. During proximaltensioning of the filaments 30, the reduced wall thickness mayfacilitate outward radial expansion of proximal section 46 over a bottomsurface of the fascia tissue layer 3 with the result being the proximalsection 46 is mechanically stopped from proximal movement or beingpulled back through the puncture hole 50 during tensioning of thefilaments 30.

In some instances, the proximal section 46 of the collapsible tubeembodiment 26 flares to a larger outer transverse dimension from aposition which is distal of the proximal end 84 of the collapsible tube26 to a position at the proximal end 84 of the collapsible tube 26.During proximal tensioning of the filaments 30, the flared expanded wall76 allows for a wider distribution of compressive force by the proximalend 84 of the collapsible tube 26 against the bottom surface of thefascia tissue layer 3. Outward radial expansion of proximal section 46may also be facilitated by the flared configuration. Such a flaredproximal end configuration of the collapsible tube embodiment shown inFIG. 9C may be useful to mechanically stop the proximal end 84 of thecollapsible tube 26 and prevent proximal movement of the proximal end 84or the proximal end 84 from being pulled back through the puncture hole50 during tensioning of the filaments 30.

Embodiments of the vascular closure device 24 may include any suitableconfiguration of the filaments 30 and or filament material includingsuture material. In some cases the suture material of the filaments 30may be configured as a monolithic strand, and in some other cases thesuture material may be braided. For some embodiments, bio-absorbablesuture may be utilized. Further, in some cases, the suture material maybe coated with any suitable coating such as a hydrophilic coating or anantimicrobial coating. In some instances, the size of the suture of somefilament embodiments 30 may vary from U.S.P. #1 to U.S.P. #4 and mayalso include suture materials such as 2/0 suture to 3/0 suture, or otherhigh strength filament 30 of the same or similar diameter. As discussedabove, the collapsible tubes 26 may be configured to slide easily overthe respective filament 30 and may also be configured with a minimalouter transverse dimension such that the collapsible tubes 26 do notinterfere with the deployment of the anchor deployers 28. In some cases,the ratio of the outer transverse dimension of the collapsible tube 26to an outer transverse dimension of the filament 30 may be from about1.5:1 to about 4:1.

Some vascular closure device embodiments 24 may also include a filamentgrip feature that may be configured as the lock ring 40 and that mayfunction to mechanically secure the filaments 30 in fixed relation toeach other and the fascia tissue layer 3 after proximal tensioning andaxial collapse of the collapsible tubes 26. In some cases the lock ring40 may be disposed on the distal end 42 of the housing 36 as shown inFIG. 6A. The lock ring 40 is disposed adjacent and about the filaments30 at the distal end 42 of the housing 36, and may be configured tocompress and secure the filaments 30 relative to each other oncedeployed from the distal end 42 of the housing 36 so as to transitionfrom an expanded state on the housing 36 to a self-contracting relaxedstate with a compressive inward radial force on the filaments 30. Forsome embodiments the lock ring 40 may be configured as a self-retractingcoil having a central lumen 41 which is disposed about the filaments 30.In some cases the lock ring 40 may be sized in order to allow freemovement of the filaments 30 when the self-retracting coil is disposedin an expanded state. In turn the lock ring 40 may have an interiorsurface of the central lumen 41 that is sized and configured to compressthe filaments 31 when in the lock ring 40 is disposed a retracted stateas shown in FIG. 15.

As discussed above, the anchors 32 may act to mechanically capturesurrounding tissue after deployment of the anchor deployers 28 and uponproximal tensioning of the filaments 30. In some cases the anchors 32may optionally be sized and configured to present a surface areaadjacent to the connection between the filament 30 and the anchor 32that is wider than an outer transverse dimension of the collapsible tubewhich may prevent the filament 30 and anchor 32 from being pulledthrough the inner lumen of the collapsible tube 26 upon tensioning ofthe filaments 30 against the lower surface of the fascia tissue layer 3.In some instances the anchors 32 may be configured to rotate, pivot orexpand after being deployed from the distal end 56 of the respectivedeployment rods 34. In some cases the anchors 32 may be formed from ahypo tube section which has an inclined sharpened end portion with therespective filament 30 secured to a mid-portion of the anchor 32. Insome cases, the distal end of the filament 30 may be secured to theanchor 32 with adhesive, a knot, an enlarged distal portion of thefilament 30 captured by a hole in the anchor 32 or the like.

FIGS. 10-15 depict a method for the deployment of the vascular closuredevice 24 into a vascular access site for closure of the access passage38 in order to prevent blood leakage from the access hole 44 in theartery 5 of the vascular access site. As shown in FIG. 10, the distalend 42 of a housing 36 of the vascular closure device 24 may be disposedto a position adjacent the access passage 38 in the fascia tissue layer3, as well as the deploying of a plurality of anchor deployers 28 fromthe distal section 54 of the housing 36 in a distal and radially outwarddirection from the housing 36 and into the tissue layer 3 in positionswhich are disposed about the access passage 38 in the fascia tissuelayer 3. The plurality of anchor deployers 28 of the vascular closuredevice 24 are shown to be penetrating the tissue layer 3 and extendingthrough the tissue layer 3 until a proximal end 84 of the collapsibletube 26 of each of the plurality of anchor deployers 28 extends distallybeyond the lower surface 86 of the tissue layer 3. FIG. 11 depictsproximally withdrawing the deployment rods 34 of each of the pluralityof anchor deployers 28 from respective anchors 32 and into the distalsection 54 of the housing 36 of the vascular closure device 24.

FIG. 12 depicts partially retracting the anchor 32 of each of the anchordeployers 28 by proximally retracting a filament 30 which is secured tothe respective anchor 32. FIGS. 13 and 14 depict axially compressing thecollapsible tube 26 of each of the plurality of anchor deployers 28between the respective anchor 32 and lower surface 86 of the tissuelayer 3 by applying tension to the filament 30 which is secured to theanchor 32 and which is disposed within an inner lumen of the collapsibletube 26. Tension is applied to the filament 30 until the collapsibletube 26 shortens in axial length and expands in an outward radialdirection adjacent the access passage 38. Tension may be applied to thefilaments 30 from the distal section 54 of the housing 36 by actuationof the filament tensioner 70 in order to reduce a distance between theanchors 32, thereby drawing the anchors 32 and adjacent tissue of thetissue layer 3 radially inward so as to reduce the size of the accesspassage 38 in the tissue layer 3.

In some cases, a filament grip which may be configured as aself-contracting lock ring 40 as shown in FIG. 15 may be deployed ontothe filaments 30 in order to secure the filaments 30 relative to eachother at the lock ring 40 after the size of the access passage 38 in thetissue layer 3 has been reduced. The self-contracting lock ring 40 maybe deployed onto the filaments 30 by sliding the self-contracting lockring 40 in an expanded state from the distal end 42 of the housing 36,then allowing the self-contracting lock ring 40 to contract to a relaxedstate over the filaments 30.

In some cases collapsible tubes 26 formed from a thrombogenic materialmay be utilized, and upon deployment into a blood field which is belowthe tissue layer thrombus may form adjacent to the collapsible tubes 26as shown in FIG. 15. Additionally, in some instances the collapsibletubes 26 may be configured with a proximal section 46 which has beenconfigured to be mechanically stopped by a bottom surface 86 of thefascia tissue layer 3 adjacent the proximal section 46 as has beendiscussed previously. In this case the method which is depicted in FIGS.10-15 may further include preferentially radially expanding and axiallycollapsing the proximal end 84 and/or proximal section 46 of thecollapsible tubes 26 against the lower surface 86 of the fascia tissuelayer 3 in an outward radial direction due to the slotted or otherwiseweakened wall structure 76 of the collapsible tubes 26 at the proximalsection 46 thereof while axially compressing the collapsible tubes 26while proximally tensioning the filaments 30. Radially expanding andaxially collapsing a proximal end 46 of collapsible tubes 26 may includein some cases splaying leafs of respective proximal ends 84 ofcollapsible tube embodiments 26 that include proximal slits 82 from theproximal ends 84 of the collapsible tubes 26 as shown in the collapsibletube embodiment of FIG. 9A.

The method which is depicted in FIGS. 10-15 may also include alternativemethods for mechanically stopping the proximal sections 46 of thecollapsible tubes 26 such as disposing a flared proximal end 84 ofcollapsible tube embodiments 26 against the lower surface 86 of thetissue layer 3 and spaced from the edge of the puncture hole 50 formedby the respective anchor deployers 28, and crumpling the proximal ends84 of the collapsible tubes 26 which have a reduced wall thickness (asshown in the collapsible tube embodiment 26 of FIG. 9B) against thelower surface 86 of the tissue layer 3.

During some surgical procedures, it may be desirable to deploy a devicethat is suitable for reducing bleeding in targeted areas without alsoclosing an access passage 38 at the same time. Such a hemostasis devicemay be intended to close “spots” of bleeding after a vascular closureprocedure, such as bleeding from a puncture hole caused by the insertionof an anchor deployer or any other suitable location. FIGS. 16 and 17show an embodiment of a hemostasis device 90 that includes a housing 92having an elongate configuration with an axial length of the housing 92may be greater than a transverse dimension of the housing 92. Thehousing 92 may also include a proximal end 94, a distal end 96, and adistal section 98.

The hemostasis device 90 may include a single anchor deployer 28 thatmay be suitably disposed within an interior volume of the housing 92 asshown in FIG. 17. The anchor deployer 28 may be configured to extendfrom the distal section 98 of the housing 92 and into target tissueduring a hemostasis procedure. The anchor deployer 28 may include thedeployment rod 34, the anchor 32, the filament 30, and the collapsibletube 26 that may be disposed over the filament 30. The collapsible tube26 may include features, materials, and dimensions which are the same asor similar to those features, materials and dimensions of collapsibletube embodiments 26 discussed above. The deployment rod 34 may have anelongate resilient configuration, and may be slidably disposed relativeto the housing 92 such that the distal end 56 of the deployment rod 34may extend distally and radially from the distal section 98 of thehousing 92 upon deployment of the anchor deployer 28.

The anchor 32 of the anchor deployer 28 may be removably secured to thedistal end 56 of the deployment rod 34. The anchor 32 may be configuredto penetrate tissue 3 in a distal direction and optionally preventtissue penetration of the fascia tissue layer 3 in a proximal direction.The anchor 32 may optionally be configured to facilitate the deploymentof the anchor deployer 28 distally into the target tissue 3 whileallowing for the mechanical capture of the anchor 32 by surroundingtissue 3 upon retraction of the deployment rod 34 and proximaltensioning of the filament 30.

The anchor deployer 28 of the hemostasis device 90 may also include thefilament 30 that may be slidably disposed within the housing 92 andwhich may include the distal end 58 that may be secured to the anchor32. The anchor deployer 28 may also include the collapsible tube 26 thatmay be disposed over and secured to a distal section of the filament 30,the distal section 60 of the filament 30 being disposed such that it isproximal of and adjacent to the anchor 32. In some cases, thecollapsible tube 26 may have an elongate configuration such that anaxial length of the collapsible tube 26 may be greater than a transversedimension of the collapsible tube 26. Additionally, the collapsible tube26 may have a wall structure 76 that may be configured to buckle in anaxial orientation upon axial compression of the collapsible tube 26.

In some instances, the housing 92 may include a guidewire lumen (notshown) which may extend the axial length of the housing 92 from theproximal end 94 to the distal end 96. The guide wire lumen may beconfigured to allow for the passage of a guidewire 8 through the housing92. In some cases, a guidewire 8 may remain within a target vessel andwithin a vascular access channel created during the percutaneouscardiovascular procedure. The guidewire lumen disposed within thehousing 92 of the hemostasis device 90 allows for the vascular closuredevice to be coupled to the guidewire 8 thereby allowing for thetracking of the hemostasis device 90 along the guidewire 8 within thevascular access passage 38 or access hole 44 the artery 5 if applicable.

The hemostasis device 90 may also include a handle 100 that may besecured to the proximal end 94 of the housing 92. The handle 100 may beutilized in order to grasp and manipulate the hemostasis device 90during a vascular closure procedure, and may include features whichcontrol the insertion of the anchor deployer 28 (via distal extension ofthe rod pusher 102), proximal retraction of the deployment rod 34,proximal tensioning of the filament 30, and in some cases deployment ofa lock ring 40. The handle 100 may include a Luer lock (not shown) whichallows for access through the handle 100 to the guidewire lumen whichmay be disposed within the housing 92.

The rod pusher 102 may be operatively coupled to the deployment rod 34,in some cases the rod pusher 102 may be operatively coupled to aproximal end of the deployment rod 34. The rod pusher 102 may beconfigured such that it can slide within the handle 100 both distallyand proximally, thereby allowing for the rod pusher 102 to be utilizedin order to distally extend or proximally retract the deployment rod 34during a vascular closure procedure. The handle 100 may also include afilament tensioner 104 which may be operatively coupled to the filament30. The filament tensioner 104 may be configured such that it can slideproximally within the handle 100, thereby allowing for the filamenttensioner 104 to be utilized in order to proximally tension the filament30.

The hemostasis device 90 may also include a filament grip feature thatmay be configured as the lock ring 40 and that may function tomechanically capture the filament 30 after proximal tensioning. In somecases the lock ring 40 may be disposed on the distal end 96 of thehousing 92 (see FIG. 17) adjacent the filament 30, and may be configuredto compress and secure the filament 30 once deployed from an expandedstate on the distal end 96 of the housing 92. For some embodiments thelock ring 40 may be configured as a self-retracting coil having acentral lumen 41 which may be disposed about the filament 30. In somecases the lock ring 40 may be sized in order to allow free movement ofthe filament 30 when the self-retracting lock ring 40 is disposed in anexpanded state. In turn the lock ring 40 may have an interior surface ofthe central lumen 41 that is configured to compress and be secured tothe filament 30 when the lock ring 40 is disposed a retracted state.

As discussed above, the anchor 32 may optionally act to mechanicallycapture surrounding tissue after deployment of the anchor deployer 28and upon proximal tensioning of the filament. In some cases the anchor32 may be sized and configured to present a surface area adjacent to theconnection between the filament 30 and the anchor 32 that is wider thanan outer transverse dimension of the collapsible tube which may preventthe filament 30 and anchor 32 from being pulled through the inner lumenof the collapsible tube 26 upon tensioning of the filament 30 againstthe lower surface of the fascia tissue layer 3. In some instances theanchor 32 may be configured to rotate, pivot or expand after beingdeployed from the distal end 56 of the deployment rod 34. In some casesthe anchor 32 may be formed from a hypo tube section which has aninclined sharpened end portion.

FIGS. 18-21 depict a method for the deployment of the hemostasis device90 in order to prevent or reduce blood leakage from a vascular closuresite in a tissue layer 3. FIG. 18 depicts disposing a distal end 96 of ahousing 92 of the hemostasis device 90 to a position adjacent the accesspassage 38 in the tissue layer 3, as well as the deploying of the anchordeployer 28 from the distal section 98 of the housing 92 in a distaldirection from the housing 92 in the tissue layer 3. The anchor deployer28 may be deployed distally by distally advancing the deployment rod 34from the housing 92. The anchor deployer 28 of the hemostasis device 90is shown to be penetrating the tissue layer 3 and extending through thetissue layer 3 until a proximal end 84 of the collapsible tube 26 of theanchor deployer 28 extends distally beyond a lower surface 86 of thetissue layer 3. FIG. 19 depicts proximally withdrawing the deploymentrod 34 of the anchor deployer 28 from the anchor 32 and into the distalsection 98 of the housing 92.

FIG. 19 depicts partially retracting the anchor 32 of the anchordeployer 28 by proximally retracting the filament 30 which may besecured to the anchor 32 with the filament tensioner 104. FIG. 20depicts axially compressing the collapsible tube 26 of the anchordeployer 28 between the anchor 32 and lower surface 86 of the tissuelayer 3 by applying tension to the filament 30 which may be secured tothe anchor 32 and which may be disposed within an inner lumen of thecollapsible tube 26. Tension is applied to the filament 30 until thecollapsible tube 26 shortens in axial length and expands in an outwardradial direction adjacent the puncture hole 50.

In some Instances, the lock ring 40 which may be configured as aself-contracting lock ring (see FIG. 17) may be deployed onto thefilament 30 after tensioning in order to secure the filament 30 relativeto the fascia tissue layer 3 to prevent distal movement of the filament30 through the tissue layer 3. The self-contracting lock ring 40 may bedeployed onto the filament 30 by sliding the self-contracting lock ring40 in an expanded state from the distal end 96 of the housing 92, thenallowing the self-contracting lock ring 40 to contract to a relaxedstate over the filament 30.

In some cases the collapsible tube 26 may be formed from a thrombogenicmaterial, and upon deployment into a blood field which is below thetissue layer 3 thrombus may form adjacent to the collapsible tube 26 asshown in FIG. 21. Additionally, in some instances the collapsible tube26 may be configured with a proximal section which has been configuredto be mechanically stopped from passing back through the puncture hole50 as has been discussed previously. In this case the method which isdepicted in FIGS. 18-21 may further include radially expanding andaxially collapsing the proximal end 84 of the collapsible tube 26against the lower surface 86 of the tissue layer 3 in an outward radialdirection while axially compressing the collapsible tube 26 whileproximally tensioning the filament 30. Radially expanding and axiallycollapsing a proximal end 84 of collapsible tube 26 may include in somecases splaying leafs of a proximal end 84 of the collapsible tube 26that include proximal slits 82 from the proximal end 84 of thecollapsible tube 26.

The method which is depicted in FIGS. 18-21 may also include alternativemethods for mechanically stopping the proximal section 46 of thecollapsible tube 26 from passing through the puncture hole 50 in aproximal direction such as disposing a flared proximal end 84 of thecollapsible tube 26 against the lower surface 86 of the tissue layer 3and spaced from the puncture hole 50 formed by deployment of the anchordeployer 28, and crumpling the proximal end 84 of the collapsible tube26 which has a reduced wall thickness against the lower surface 86 ofthe tissue layer 3.

Embodiments illustratively described herein suitably may be practiced inthe absence of any element(s) not specifically disclosed herein. Thus,for example, in each instance herein any of the terms “comprising,”“consisting essentially of,” and “consisting of” may be replaced witheither of the other two terms. The terms and expressions which have beenemployed are used as terms of description and not of limitation and useof such terms and expressions do not exclude any equivalents of thefeatures shown and described or portions thereof, and variousmodifications are possible. The term “a” or “an” can refer to one of ora plurality of the elements it modifies (e.g., “a reagent” can mean oneor more reagents) unless it is contextually clear either one of theelements or more than one of the elements is described. Thus, it shouldbe understood that although embodiments have been specifically disclosedby representative embodiments and optional features, modification andvariation of the concepts herein disclosed may be resorted to by thoseskilled in the art, and such modifications and variations are consideredwithin the scope of this disclosure.

With regard to the above detailed description, like reference numeralsused therein refer to like elements that may have the same or similardimensions, materials and configurations. While particular forms ofembodiments have been illustrated and described, it will be apparentthat various modifications can be made without departing from the spiritand scope of the embodiments of the invention. Accordingly, it is notintended that the invention be limited by the forgoing detaileddescription.

What is claimed is:
 1. A vascular closure device, comprising: a housingincluding an elongate configuration with an axial length greater than atransverse dimension thereof, a proximal end, a distal end and a distalsection; a plurality of anchor deployers configured to extend from thedistal section of the housing, each anchor deployer comprising: adeployment rod which is slidably disposed relative to the housing andwhich includes an elongate resilient configuration and a distal end thatextends distally and radially from the distal section of the housing, ananchor which is removably secured to the distal end of the deploymentrod and which is configured to penetrate tissue in a distal direction, afilament which is slidably disposed within the housing and whichincludes a distal end which is secured to the anchor, and a collapsibletube disposed over a distal section of the filament proximal of andadjacent to the anchor, the collapsible tube including an elongateconfiguration having an axial length greater than a transverse dimensionthereof and a wall structure that is configured to shorten in axiallength and radially expand upon axial compression; and and wherein thefilaments of the plurality of anchor deployers are slidably disposedwithin the housing adjacent each other at the distal section of thehousing.
 2. The vascular closure device of claim 1 wherein the housingfurther comprises a guidewire lumen extending an axial length thereof.3. The vascular closure device of claim 1 further comprising a handlesecured to the proximal end of the housing.
 4. The vascular closuredevice of claim 1 further comprising a rod pusher operatively coupled tothe deployment rod.
 5. The vascular closure device of claim 1 furthercomprising a filament tensioner operatively coupled to the filament ofeach anchor deployer.
 6. The vascular closure device of claim 1 whereinthe collapsible tubes comprise a distal section which tapers distally toa reduced outer transverse dimension.
 7. The vascular closure device ofclaim 1 wherein the collapsible tubes comprise a distal end which issecured to the respective filaments adjacent the anchor.
 8. The vascularclosure device of claim 1 wherein the collapsible tubes comprise adistal end which is secured directly to the respective anchors.
 9. Thevascular closure device of claim 1 wherein the collapsible tubescomprise a longitudinal slit in a middle section of a wall thereof. 10.The vascular closure device of claim 9 wherein the collapsible tubescomprise a plurality of longitudinal slits in a middle section in thewall thereof.
 11. The vascular closure device of claim 1 wherein thecollapsible tubes comprise a material selected from the group consistingof polyurethane, polyethylene terephthalate (PET), polyetheretherkeytone (PEEK), polytetrafluoroethylene (PTFE), acrylic, silicone,polypropylene, and polyester.
 12. The vascular closure device of claim 1wherein the collapsible tubes comprise a thrombogenic material.
 13. Thevascular closure device of claim 12 wherein the thrombogenic materialcomprises a material selected from the group consisting of collagen,fibrin, fibrinogen, gelatin, polylactic acid (PLA), polyglycolic acid(PGA), alginate and fibronectin.
 14. The vascular closure device ofclaim 1 wherein the collapsible tubes comprise a hydrogel material thatswells to a larger volume over time in an aqueous environment.
 15. Thevascular closure device of claim 14 wherein the hydrogel materialcomprises a material selected from the group consisting of fibrin,collagen, gelatin, hyaluronic acid, alginate, agarose, poly(ethyleneglycol), poly(acrylic acid), poly(vinyl alcohol), polypeptides, andpoly(vinyl pyrrolidone).
 16. The vascular closure device of claim 1wherein the collapsible tubes comprise a slit through the wall of thetube extending distally from the proximal end of the collapsible tube.17. The vascular closure device of claim 16 wherein the collapsible tubecomprises a plurality of slits through the wall extending distally fromthe proximal end of the collapsible tube.
 18. The vascular closuredevice of claim 17 wherein the plurality of slits through the wallextending distally from the proximal end of the collapsible tubecomprise a length of about 1 mm to about 4 mm.
 19. The vascular closuredevice of claim 1 wherein the wall thickness of the collapsible tubestapers to a reduced wall thickness from a position which is distal ofthe proximal end of the collapsible tube to a position at the proximalend of the collapsible tube.
 20. The vascular closure device of claim 1wherein the collapsible tubes flare proximally to a larger outertransverse dimension from a position which is distal of the proximal endof the collapsible tube to a position at the proximal end of thecollapsible tube.
 21. The vascular closure device of claim 1 wherein thecollapsible tubes comprise an axial length of about 3 mm to about 15 mm.22. The vascular closure device of claim 1 wherein the collapsible tubescomprise an outer transverse dimension of about 0.5 mm to about 2 mm.23. The vascular closure device of claim 1 further comprising a filamentgrip that is disposed on the distal end of the housing adjacent thefilaments and which is configured to compress and secure the filamentsrelative to each other once deployed from the distal end of the housing.24. The vascular closure device of claim 23 wherein the filament gripcomprises a lock ring disposed about the filaments which includes aself-retracting coil with a central lumen which is disposed about thefilaments, which is sized to allow free movement of the filaments withthe self-retracting coil in an expanded state and which has an interiorsurface of the central lumen that is configured to compress thefilaments when in a retracted state.
 25. The vascular closure device ofclaim 1 further comprising a lateral surface configured to extendradially from a distal extension of the housing while the lateralsurface is disposed within a blood vessel to provide a reference pointbetween axial relative positions of the wall of the blood vessel and theanchors prior to deployment of the anchors.
 26. The vascular closuredevice of claim 25 wherein the anchors can be deployed a predeterminedaxial distance from the wall of the blood vessel as measured from thelateral surface which is disposed against the wall of the blood vessel.27. A method of preventing blood leakage from a closure site of apassage in a tissue layer, comprising: disposing a distal end of ahousing of a vascular closure device to a position adjacent the passagein the tissue layer; deploying a plurality of anchor deployers from adistal section of the housing in a distal and radially outward directionfrom the housing into the tissue layer in positions disposed about thepassage in the tissue layer; penetrating the tissue layer with theplurality of anchor deployers of the vascular closure device andextending each of the plurality of anchor deployers distally through thetissue layer until a proximal end of a collapsible tube of each of theplurality of anchor deployers extends distally beyond a lower surface ofthe tissue layer; proximally retracting an anchor of each of the anchordeployers by proximally retracting a filament which is secured thereto;axially compressing the collapsible tube of each of the plurality ofanchor deployers between the respective anchor and lower surface of thetissue layer by applying tension to the filament which is secured to theanchor and which is disposed within an inner lumen of the collapsibletube until the collapsible tube shortens in axial length and expands inan outward radial direction adjacent the passage; and applying tensionto the filaments from a distal section of the housing to reduce adistance between the anchors drawing the anchors and adjacent tissue ofthe tissue layer radially inward so as to reduce the size of the passagein the tissue layer.
 28. The method of claim 27 further comprisingproximally withdrawing deployment rods of each of the plurality ofanchor deployers from respective anchors and into the distal section ofthe housing.
 29. The method of claim 27 further comprising deploying afilament grip onto the filaments and securing the filaments relative toeach other at the filament grip after the size of the passage in thetissue layer has been reduced.
 30. The method of claim 39 whereindeploying the filament grip onto the filaments comprises sliding aself-contracting lock ring in an expanded state from a distal end of thehousing and allowing the self-contracting lock ring to contact to arelaxed state over the filaments.
 31. The method of claim 27 wherein thecollapsible tubes comprise a thrombogenic material, the collapsibletubes are deployed in a blood field below the tissue layer, and furthercomprising forming thrombus adjacent the collapsible tubes.
 32. Themethod of claim 27 further comprising radially expanding and axiallycollapsing a proximal end of the collapsible tubes against the lowersurface of the tissue layer in an outward radial direction while axiallycompressing the collapsible tubes.
 33. The method of claim 32 whereinradially expanding the proximal ends of the collapsible tubes comprisessplaying leafs of respective proximal ends of the collapsible tubes thatinclude slits from the proximal ends thereof.
 34. The method of claim 27comprising disposing a flared proximal end of the collapsible tubeagainst the lower surface of the tissue layer and spaced from a lumenformed by the respective anchor deployers.
 35. The method of claim 27comprising crumpling the proximal ends of the collapsible tubes whichhave a reduced wall thickness against the lower surface of the tissuelayer.
 36. A hemostasis device, comprising: a housing including anelongate configuration with an axial length greater than a transversedimension thereof, a proximal end, a distal end and a distal section; ananchor deployer comprising: a deployment rod which is slidably disposedrelative to the housing and which includes an elongate resilientconfiguration and a distal end that extends distally and radially fromthe distal section of the housing, an anchor which is removably securedto the distal end of the deployment rod and which is configured topenetrate tissue in a distal direction and prevent tissue penetration ina proximal direction, a filament which is slidably disposed within thehousing and which includes a distal end which is secured to the anchor,and a collapsible tube disposed over a distal section of the filamentproximal of the anchor, the collapsible tube including an elongateconfiguration having an axial length greater than a transverse dimensionthereof and a wall structure that is configured to buckle in an axialorientation upon axial compression.
 37. The hemostasis device of claim36 further comprising a handle secured to the proximal end of thehousing.
 38. The hemostasis device of claim 36 further comprising a rodpusher operatively coupled to the deployment rod.
 39. The hemostasisdevice of claim 36 further comprising a filament tensioner operativelycoupled to the filament.
 40. The hemostasis device of claim 36 whereinthe collapsible tube comprises a distal section which tapers distally toa reduced outer transverse dimension.
 41. The hemostasis device of claim36 wherein the collapsible tube comprises a longitudinal slit in amiddle section of a wall thereof.
 42. The hemostasis device of claim 41wherein the collapsible tube comprises a plurality of longitudinal slitsin a middle section in the wall thereof.
 43. The hemostasis device ofclaim 36 wherein the collapsible tube comprises a material selected fromthe group consisting of polyurethane, PET, PEEK, acrylic, silicone,polypropylene, and polyester.
 44. The hemostasis device of claim 36wherein the collapsible tube comprises a thrombogenic material.
 45. Thehemostasis device of claim 44 wherein the thrombogenic materialcomprises a material selected from the group consisting of collagen,fibrin, fibrinogen, gelatin, polylactic acid (PLA), polyglycolic acid(PGA), alginate and fibronectin.
 46. The hemostasis device of claim 36wherein the collapsible tube comprises a hydrogel material that swellsto a larger volume over time in an aqueous environment.
 47. Thehemostasis device of claim 46 wherein the hydrogel material comprises amaterial selected from the group consisting of fibrin, collagen,gelatin, hyaluronic acid, alginate, agarose, poly(ethylene glycol),poly(acrylic acid), poly(vinyl alcohol), polypeptides, and poly(vinylpyrrolidone).
 48. The hemostasis device of claim 36 wherein thecollapsible tube comprises a slit through the wall of the tube extendingdistally from the proximal end of the collapsible tube.
 49. Thehemostasis device of claim 48 wherein the collapsible tube comprises aplurality of slits through the wall extending distally from the proximalend of the collapsible tube.
 50. The hemostasis device of claim 49wherein the plurality of slits through the wall extending distally fromthe proximal end of the collapsible tube comprise a length of about 1 mmto about 4 mm.
 51. The hemostasis device of claim 36 wherein the wallthickness of the collapsible tube tapers to a reduced wall thicknessfrom a position which is distal of the proximal end of the collapsibletube to a position at the proximal end of the collapsible tube.
 52. Thehemostasis device of claim 36 wherein the collapsible tube flaresproximally to a larger outer transverse dimension from a position whichis distal of the proximal end of the collapsible tube to a position atthe proximal end of the collapsible tube.
 53. The hemostasis device ofclaim 36 wherein the collapsible tube comprises an axial length of about3 mm to about 15 mm.
 54. The hemostasis device of claim 36 wherein thecollapsible tube comprises an outer transverse dimension of about 0.5 mmto about 2 mm.
 55. The hemostasis device of claim 36 further comprisinga filament grip that is disposed on the distal end of the housingadjacent the filament and which is configured to be secured to thefilament and prevent passage of the filament distally through the tissuelayer.
 56. The hemostasis device of claim 55 wherein the filament gripcomprises a lock ring disposed about the filament which includes aself-retracting coil with a central lumen which is disposed about thefilament, which is sized to allow free movement of the filamenttherethrough with the self-retracting coil in an expanded state andwhich has an interior surface of the central lumen that is configured tocompress the filament when in a retracted state.
 57. A method ofpreventing blood leakage from a tissue layer, comprising: disposing adistal end of a housing of a hemostasis device at a position adjacentthe tissue layer; deploying an anchor deployer from a distal section ofthe housing in a distal direction from the housing into the tissuelayer; penetrating the tissue layer with the anchor deployer andextending the anchor deployer distally through the tissue layer until aproximal end of a collapsible tube of the anchor deployer extendsdistally beyond a lower surface of the tissue layer; proximallyretracting an anchor of the anchor deployer by proximally retracting afilament which is secured thereto; and axially compressing thecollapsible tube between the anchor and lower surface of the tissuelayer by applying tension to the filament which is secured to the anchorand which is disposed within an inner lumen of the collapsible tubeuntil the collapsible tube shortens in axial length and expands in anoutward radial direction.
 58. The method of claim 57 wherein deployingthe anchor deployer comprises distally advancing a deployment rod in adistal direction and further comprising proximally withdrawing thedeployment rod from the anchor and into the distal section of thehousing.
 59. The method of claim 57 further comprising deploying afilament grip onto the filament and securing the filament to preventdistal movement of the filament through the tissue layer.
 60. The methodof claim 59 wherein deploying the filament grip onto the filamentcomprises sliding a self-contracting lock ring in an expanded state froma distal end of the housing and allowing the self-contracting lock ringto contact to a relaxed state over the filament.
 61. The method of claim57 wherein the collapsible tube comprises a thrombogenic material, thecollapsible tube is deployed in a blood field below the tissue layer,and further comprising forming thrombus adjacent the collapsible tube.62. The method of claim 57 further comprising radially expanding andaxially collapsing a proximal end of collapsible tube against the lowersurface of the tissue layer in an outward radial direction while axiallycompressing the collapsible tube.
 63. The method of claim 62 whereinradially expanding the proximal end of the collapsible tube comprisessplaying leafs of a proximal end of the collapsible tubes that includesslits from the proximal end thereof.
 64. The method of claim 57comprising disposing a flared proximal end of the collapsible tubeagainst the lower surface of the tissue layer which is spaced from apuncture hole formed by the deployment of the anchor deployer.
 65. Themethod of claim 57 further comprising crumpling the proximal end of thecollapsible tube which has a reduced wall thickness against the lowersurface of the tissue layer.